September 2008 – Federal Register Recent Federal Regulation Documents

The Grain Inspection, Packers and Stockyards Administration (GIPSA) is seeking nominations for individuals to serve on the Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets twice annually to advise GIPSA on the programs and services it delivers under the U.S. Grain Standards Act. Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) to request an extension without change of a currently approved collection of information: 3220-0038, Medical Reports. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine (1) The practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date. Under Sections 2(a)(1)(iv), 2(a)(2) and 2(a)(3) of the Railroad Retirement Act (RRA), annuities are payable to qualified railroad employees whose physical or mental condition is such that they are unable to (1) work in their regular occupation (occupational disability); or (2) work at all (permanent total disability). The requirements for establishment of disability and proof of continuance of disability are prescribed in 20 CFR 220. Under Sections 2(c)(1)(ii)(c) and 2(d)(1)(ii) of the RRA, annuities are also payable to qualified spouses and widow(ers), respectively, who have a qualified child who is under a disability which began before age 22. Annuities are also payable to surviving children on the basis of disability under Section 2(d)(1)(iii)(C) if the child's disability began before age 22 and to widow(ers) on the basis of disability under section 2(d)(1) (i)(B). To meet the disability standard, the RRA provides that individuals must have a permanent physical or mental condition such that they are unable to engage in any regular employment. Under section 2(d)(1)(v) of the RRA, annuities are also payable to remarried and surviving divorced spouses on the basis of, inter alia, disability or having a qualified disabled child in care. However, the disability standard in these cases is that found in the Social Security Act. That is, individuals must be able to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment. The RRB also determines entitlement to a period of early disability and early Medicare entitlement for qualified claimants in accordance with Section 216 of the Social Security Act. When making disability determinations, the RRB needs evidence from acceptable medical sources. The RRB currently utilizes Forms G-3EMP, Report of Medical Condition by Employer; G-197, Authorization to Release Medical Information, G-250, Medical Assessment; G-250a, Medical Assessment of Residual Functional Capacity; G-260, Report of Seizure Disorder; RL-11b, Disclosure of Hospital Medical Records; RL-11d, Disclosure of Medical Records from a State Agency; and RL-250, Request for Medical Assessment, to obtain the necessary medical evidence. The RRB proposes no changes to the information collection. Completion of the forms is voluntary. One response is requested of each respondent. Previous Requests for Comments: The RRB has already published the initial 60-day notice (73 FR 22183 on April 24, 2008) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``End-of-Phase 2A Meetings.'' This draft guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs) who seek guidance on employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo) to design trials for better dose response estimation, dose selection, and other appropriate issues. This draft guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and to improve the quality of drug applications through early meetings with sponsors.

The Commissioner of Social Security gives notice that an agreement coordinating the United States (U.S.) and Danish social security programs will enter into force on October 1, 2008. The agreement with Denmark, which was signed on June 13, 2007, is similar to U.S. social security agreements already in force with 21 other countriesAustralia, Austria, Belgium, Canada, Chile, Finland, France, Germany, Greece, Ireland, Italy, Japan, Korea (South), Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Agreements of this type are authorized by section 233 of the Social Security Act (42 U.S.C. 433). Like the other agreements, the U.S.-Danish agreement eliminates dual social security coveragethe situation that exists when a worker from one country works in the other country and is covered under the social security systems of both countries for the same work. Without such agreements in force, when dual coverage occurs, the worker, the worker's employer, or both may be required to pay social security contributions to the two countries simultaneously. Under the U.S.- Danish agreement, a worker who is sent by an employer in the U.S. to work in Denmark for 5 years or less remains covered only by the U.S. social security program. Similarly, a worker who is sent by an employer in Denmark to work in the U.S. for 3 years or less remains covered only by the Danish social security program. The agreement includes additional rules that eliminate dual U.S. and Danish coverage in other work situations. The agreement also helps eliminate situations where workers suffer a loss of benefit rights because they have divided their careers between the two countries. Under the agreement, workers may qualify for partial U.S. benefits or partial Danish benefits based on combined (totalized) work credits from both countries. Individuals who wish to obtain copies of the agreement or want more information about its provisions may write to the Social Security Administration, Office of International Programs, Post Office Box 17741, Baltimore, MD 21235-7741 or visit the Social Security Web site at https://www.socialsecurity.gov/international.

OSHA solicits public comment concerning its proposal to extend OMB approval of the information collection requirements specified in the 13 Carcinogens Standard (29 CFR 1910.1003).

This action restructures the restricted areas and other special use airspace (SUA) located in the vicinity of Fort Drum, NY. The Air National Guard (ANG) requested redesign of existing restricted airspace R-5201, known as the Adirondack Airspace Complex, by establishing two new restricted areas: R-5202A and R-5202B, and by restructuring the military operations areas (MOA) contained in the Adirondack Airspace Complex. Unlike restricted areas, which are designated under 14 CFR part 73, MOAs are not rulemaking airspace actions. However, since these MOAs form an integral part of the Adirondack Airspace Complex, the FAA is including a description of the associated MOA changes in this rule. The MOA changes described here will also be published in the National Flight Data Digest (NFDD). The ANG requested these airspace changes to provide the additional SUA needed to conduct more realistic aircrew training in the Adirondack Airspace Complex.

The U.S. Army Corps of Engineers, Los Angeles District (Regulatory Division), in coordination with the Port of Los Angeles, has completed a Draft Environmental Impact Statement/Environmental Impact Report (EIS/EIR) for the San Pedro Waterfront Project, encompassing approximately 400 acres of land and water primarily along the west side of the Main Channel westward to Harbor Boulevard from the Vincent Thomas Bridge southward to Inner Cabrillo Beach in the Port of Los Angeles. The Port of Los Angeles requires authorization pursuant to section 404 of the Clean Water Act, section 10 of the Rivers and Harbors Act, and section 103 of the Marine Protection, Research, and Sanctuaries Act, to implement various regulated activities in and over waters of the U.S. associated with redeveloping San Pedro Waterfront, which would include the following elements:

This notice announces final environmental actions taken by the Federal Transit Administration (FTA) for public transportation projects in the following areas: Fort Collins, Colorado; Belle Glade, Florida; Gustavus, Alaska; Dallas, Texas; West Covina, California; and Andover, New Jersey. The purpose of this notice is to announce publicly the environmental decisions by FTA on the subject projects and to activate the limitation on any claims that may challenge these final environmental actions.

The FAA is revising an earlier NPRM for an airworthiness directive (AD) that applies to all Airbus Model A310 series airplanes and Model A300-600 series airplanes. The original NPRM would have required superseding two existing ADs. One existing AD applies to certain Airbus Model A310 series airplanes and currently requires repetitive inspections for cracking of the flap transmission shafts, and replacement of the transmission shafts if necessary. That existing AD also provides an optional terminating action for the repetitive inspections. The other existing AD applies to all Airbus Model A310 and A300-600 series airplanes and currently requires a one-time inspection of the trimmable horizontal stabilizer actuator, corrective actions if necessary, and follow-on repetitive tasks. The original NPRM would have added revising the Airworthiness Limitations Section of the Instructions for Continued Airworthiness to incorporate new limitations and maintenance tasks for aging systems maintenance. The original NPRM resulted from the manufacturer's determination that life limitations and maintenance tasks are necessary in order to ensure continued operational safety of the affected airplanes. This new action revises the original NPRM by reducing the initial compliance times. We are proposing this supplemental NPRM to prevent reduced structural integrity of these airplanes due to the failure of system components.

This notice announces the issuance and availability of Advisory Circular (AC) 120-16E, ``Air Carrier Maintenance Programs''. This advisory circular (AC) is an update of AC 120-16D that was issued in 2003. It describes the scope, content, and functions of air carrier aircraft maintenance programs. It explains the background of these programs as well as the Federal Aviation Administration's regulatory requirements. Each of the 10 elements of air carrier maintenance programs is also described and explained. The material in this AC is not mandatory and does not constitute a regulation. However, when ``must'' or ``will'' are used in this AC, such use reflects actual regulatory requirements.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/689,746, filed June 10, 2005, now abandoned [HHS Ref. No. E-089-2005/0-US-01]; PCT Patent Application No. PCT/ US2006/22401, filed June 7, 2006, now abandoned [HHS Ref. No. E-089- 2005/0-US-02]; U.S. Patent Application No. 11/917,036, filed December 10, 2007 [HHS Ref. No. E-089-2005/0-US-03]; European Patent Application No. 06772641.4, filed December 7, 2007, which published as 1888064 on February 20, 2008 [HHS Ref. No. E-089-2005/0-EP-04]; Australian Patent Application No. 2006258035, filed November 30, 2007 [HHS Ref. No. E- 089-2005/0-AU-05]; Japanese Patent Application No. 2008-515947, filed December 7, 2007 [HHS Ref. No. E-089-2005/0-JP-06]; and Canadian Patent Application No. 2609577, filed November 23, 2007 [HHS Ref. No. E-089- 2005/0-CA-07], all of which are entitled ``Benztropinamine Analogs as Dopamine Uptake Inhibitors'' (Inventors: Amy Newman and Jonathan Katz, NIDA) to Shire LLC, having an office in at least Basingstoke, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of benztropinamine analogs, specifically, compounds derived from Formula I, wherein B is NR \4\ and wherein R \4\ is not CH3 (methyl group) to treat psychiatric and neurological disorders.

This notice informs the public that the Secretary, Department of Homeland Security (DHS), has designated the DHS Office of Infrastructure Protection (IP) as the Sector-Specific Agency (SSA) for the Critical Manufacturing Sector under the National Infrastructure Protection Plan (NIPP). IP will now move forward with the organization and coordination processes identified in the NIPP for establishing a new critical infrastructure and key resources (CIKR) sector. These initial steps will include establishing Government and Sector Coordinating Councils, which will begin the process of full integration into the CIKR Sector Partnership, implementation of the NIPP Risk Management Framework and development of the Critical Manufacturing Sector Specific Plan. This designation also includes language changes to the NIPP identifying the new sector, which will take affect immediately and remain in effect until the NIPP is rewritten and published in 2009. These changes will include adding the Critical Manufacturing sector and its SSA to those sections of the NIPP where sectors and their SSAs are listed, referenced, or described, and amending the last sentence of the definition of ``Sector'' in the Glossary to read, ``The NIPP addresses the 17 CIKR sectors enumerated in HSPD-7 and any additional sectors created by the Secretary of Homeland Security pursuant to HSPD-7.''